Shanghai-based Abbisko Therapeutics has lined up another partner for its oncology pipeline and will receive $70 million upfront as Merck KGaA grabs commercialization rights to the biotech’s lead asset in China.

Merck KGaA will dish out up to $605.5 million total, plus double-digit percentage royalties on potential future net sales, to nab commercialization rights to Abbisko’s oral small molecule pimicotinib, which is being studied in a global Phase III for patients with tenosynovial giant cell tumor, or TGCT.

The Darmstadt, Germany-based drugmaker gets the exclusive license to market pimicotinib for all indications in mainland China, Hong Kong, Macau and Taiwan, as part of the deal, the companies said Monday morning. Merck KGaA can also opt in for global commercial rights and can choose to co-develop the CSF-1R inhibitor for other indications, they added. Abbisko has outlined plans to take pimicotinib into chronic graft-versus-host disease and pancreatic cancer.

Abbisko’s deal comes about five weeks after another biotech, Deciphera Pharmaceuticals, passed a Phase III test in TGCT. Deciphera, based near Boston, said it plans to ask for FDA approval in the second quarter of 2024 and request an EU nod in the third quarter of next year. Daiichi Sankyo’s Turalio is the only FDA-approved treatment, but it comes with a drug safety REMS program.

“We are expecting Phase III readout of topline data around Q4 next year, but because we have breakthrough therapy designation, we probably can initiate NDA sooner,” co-founder and CSO Zhui Chen told Endpoints News, noting Abbisko expects to be about six to 12 months behind Deciphera. Abbisko plans to file for approval in China, US and Europe, Chen said, noting the Phase III is underway in all three regions.

Abbisko chair Yao-chang Xu said the collaboration “provides a new model for the commercialization path” of Abbisko’s pipeline in the future, noting in a statement that the deal will speed up the “global approval and commercialization pace of pimicotinib.” Abbisko has previously formed pacts with Allist Pharmaceuticals, Eli Lilly and others.

AUTHOR: Kyle LaHucik

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